Isomeric Pharmacy Solutions is voluntarily recalling all lots of sterile products compounded and packaged by them and that remain within expiry to the hospital / user level because of FDA concerns of a lack of sterility assurance. These concerns were brought to Isomeric Pharmacy Solutions’ attention during a recent FDA inspection.
The sterile products were distributed to patients, providers, hospitals and clinics nationwide between the 4th of October 2016 and the 7th of February 2017. Whilst Isomeric Pharmacy Solutions have not received any reports of adverse events related to the recall, it is acting prudently and arranging for a return of all recalled products that remain unused.
The full list of all affected products is available here.
What do you have to do next?
Isomeric Pharmacy Solutions is notifying its customers of the recall by mail and telephone or e-mail, and is arranging for a return of all recalled products that remain unused. If you are affected by this recall and have experienced any problems that may be related to taking or using this drug product, contact your physician or health care provider. Providers who have dispensed any sterile product distributed by Isomeric Pharmacy Solutions to a patient for use out of the provider’s office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall immediately.
Isomeric Pharmacy Solutions is asking all patients and providers that received sterile compounded products between the 4th of October 2016 and the 7th of February 2017 that remain within expiry to discontinue use of the products, to quarantine any unused product until further instructions are received on how to return the product, and to contact Isomeric Pharmacy Solutions at +1-844-470-2467 between the hours of 9am-5pm MDT, Monday to Friday. Alternatively, you can send an e-mail to discuss the return of any unused sterile compounded products at [email protected].
So check your medicine cabinets to check if you have any sterile products compounded and packaged by Isomeric Pharmacy Solutions is affected.
The FDA is encouraging all health care professionals and patients to report any adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or call 1-800-332-1088.
Read the full FDA alert here.